Friday, February 29, 2008

Opinion: Recent Rx Recalls

It seems like in the past several months, a day does not go by when there is a report published in nearly every media outlet regarding globally produced products being recalled due to issues with their raw materials or their production. In many cases these products contain toxic or life threatening substances that cause a major health risk to the consumer.

Keep in mind that we in the US continue to increase our dependence upon foreign manufacture of everything from dog food to pharmaceuticals. In 2008 nearly 80% of the raw materials used in the manufacture of all pharmaceuticals consumed in the US will come from overseas.

These recalls are especially serious when these products involve consumables such as food products and pharmaceuticals that are ingested and often times will continue to be consumed or administered over a period of time with no immediate side effects until a serious health concern is apparent.

Two recent recalls are especially relevant to the Team at XStream Systems because we as a company feel that if our XT250 system was in place, we would have detected the issue before it threatened the well being of the public at large.
  • In November 2007, Ranbaxy had a recall within the US of nearly 73 million doses of its 600mg and 800mg Gabapentin. According to Ranbaxy which produces pharmaceuticals for export world wide in India, certain lots of Gabapentin showed "impurities" outside of the approved limits. Originally it was reported that Ranbaxy either had difficulties with the raw materials or in finished goods of this product.
  • The recent saga of Baxter's recent recall of all of its Heparin products. As of today it is reported that there have been over 448 adverse reactions, 21 possible related deaths to the product. Nearly 1 million doses of Heparin are sold in one month in the US. Nearly half of these doses are produced overseas and sold by Baxter. The cause of the difficulties with the Baxter Heparin apparently is being blamed on the raw materials that were used in its production.

Unfortunately these two examples only represent a fraction of the tainted, counterfeited or adulterated consumable products that are exported into the US on a daily basis.

This is especially relevant to XStream given the fact that our technology has the capability to be deployed in pre-production raw materials testing, in-production quality assurance, post-production quality control and in random distribution channel testing. The XT250's ability to be deployed on-site and be operated within seconds by non-technical resources make it the perfect technology in the collective effort to secure our Global Pharmaceutical Supply Chain.

As we have talked about before, most of the mainstream pharmaceutical manufacturers, distributors and regulatory agencies seem fixated on securing the Global Pharmaceutical Supply Chain through pedigrees, RFID tags and 2D bar codes, none of which would have or could have discovered the issues with these two particular pharmaceutical entities. Only the XT250, which has the ability to penetrate and look inside sealed packaging would have detected that there were issues with the material that made up the product.

Here's hoping that we at XStream continue to make headway in our efforts to deploy our products in pharmaceutical manufacturing, distribution and in regulatory agencies so that the instances of these tainted products reaching the consumer become less and less an issue.

We at XStream are committed to making the Global Supply Chain Safe and making certain that our partners pharmaceutical inventories are Detected-Protected and Connected.

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